Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test food: Pure white sesame oil Administration: Eat 14 g of the sesame oil or eat the oil with bread per day during the breakfast * Daily dose should be eaten within the day. If
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are experiencing feeling cold 3. Subjects who are experiencing fatigue 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who are selected relatively slow in blood flow rate at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 6. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients. Particularly allergic to sesame. 7. Subjects who have severe anemia (treatment for anemia at a clinic) 8. Subjects who are using medications (except medicine for external use, moisturizing, or sunscreen) 9. Subjects who have the smoking habit 10. Subjects who are wearing nail polish or applying cuticle oil to their nail 11. Subjects who have hangnail from fingertips of middle, ring, and little fingers 12. Subjects who have suppuration or inflammation from fingertips of middle, ring, and little fingers 13. Subjects who are chipping off the cuticle on fingernails of middle, ring, and little fingers 14. Subjects who are pregnant, breast-feeding, or planning to become pregnant 15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 16. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood flow velocity 2. Visibility of the blood vessels 3. The density of the blood vessels 4. The blood vessels diameter 5. The distance between the blood vessels 6. The length of the blood vessels 7. The shape of the blood vessels *1-7 Measure before consumption and at 4 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diacron-reactive oxygen metabolites (d-ROM) 2. Biological antioxidant potential (BAP) 3. Urinary 8-OHdG 4. Potential anti-oxidant (PAO) in blood 5. Simplified oxidative stress profile (OSP) 6. Subjective symptoms *1-6 Measure before consumption and at 4 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed